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Periprosthetic Joint Infection Bubble Study

RecruitingPhase 2Ages 18 Years - anyAllThomas Jefferson University
NCT07599865 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patients with an infected knee replacement will receive their standard of care surgical treatment of the infection, with and without additional ultrasound microbubble treatment (randomly divided 50/50 in the active and control groups). Subjects in the active group will receive a local bolus injection of antibiotics and ultrasound-active microbubbles within 24 hours of their revision surgery. The fundamental hypothesis is that a decrease in re-infection rates of at least 24% can be achieved in the active group relative to controls.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Be at least 18 years of age * Be medically stable * If female of child-bearing potential, must have a negative pregnancy test * Be conscious and able to comply with study procedures * Have read and signed the IRB-approved Informed Consent form for participating in the study * For Cohort 1, be scheduled for one- or two-stage exchange arthroplasty revision surgery for PJI of the knee * For Cohort 2, be scheduled for DAIR revision surgery for PJI of the knee Exclusion Criteria: * Females who are pregnant or nursing * Patients currently on chemotherapy requiring systemic infusion treatment * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable * Patients with a history of anaphylactic allergy to perflutren or any other components of Definity * Patients with a history of failed one- or two-stage revision for infection * Patients for which placement of a surgical drain is contraindicated * Patients in protected classes (e.g., prisoners)
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What it tests

  • Ultrasound-triggered microbubble destruction with antibiotics
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Where

3 sites
Thomas Jefferson University/Rothman Institute
Philadelphia, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, United States
UT Southwestern Medical Center
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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